Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: sham rTMS-ECT; Device: active rTMS-ECT

• Registration Number: NCT02830399
• Lead Sponsor: Centre Hospitalier du Rouvray

Brief Summary

It's a prospective, multicentric, randomized, controlled study concerning 56 patients with treatment-resistant depression (TRD). The main objective of this study was to evaluate the efficacy of priming repeated Transcranial Magnetic Stimulation (rTMS) sessions before Electroconvulsive therapy (ECT) for treatment of TRD patients. The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association.

Detailed Description

Included patients are adults, aged between 18 and 70 years, with major depression (Hamilton Rating scale for Depression, HAMD ≥ 15). Patients don't have any experience concerning repeated Transcranial Magnetic Stimulation (rTMS).

Patients with treatment-resistant depression (TRD) were assigned to two treatment groups in addition to their current pharmacotherapy regimen : one group received 5 active-rTMS before Electroconvulsive therapy (ECT) and the other one received sham-rTMS before ECT. The depressive symptoms and the cognitive functions are evaluated before rTMS, after 5 rTMS and after 5 ECT.

Study Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Study Start: 2016-07-15
• Primary Completion: 2019-07-12
• Study Completion: 2019-07-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients with Major Depressive Disorder (HAMD≥15)
• Level of resistance ≥ 3 (Thase and Rush)
• Participants who gave their informed, written consent

Exclusion Criteria

• Contraindication of Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
• History of epilepsy; severe neurological or systemic disorder that could significantly affect cognition
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham rTMS-ECT	sham rTMS-ECT	5 sham rTMS before 5 bilateral ECT
active rTMS-ECT	active rTMS-ECT	5 active high frequency rTMS before 5 bilateral ECT

Primary Outcome Measures

Name	Time	Method
Relative improvement of the Hamilton Rating Scale for Depression 21-items score	Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion

Trial Locations

Locations (3)

Centre Esquirol- CHU de Caen; 🇫🇷 Caen, France

Centre Hospitalier Laborit; 🇫🇷 Poitiers, France

Centre Hospitalier du Rouvray; 🇫🇷 Sotteville-lès-Rouen, France